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Famotidine by Wal-Mart Stores, Inc.

Dosage form: tablet, film coated
Ingredients: FAMOTIDINE 20mg
Labeler: Wal-Mart Stores, Inc.
NDC Code: 49035-505


Drug Facts

Active ingredient (in each tablet)

Famotidine USP 20 mg

Purpose

Acid reducer

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings


Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use
  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • if you have kidney disease, except under the advice and supervision of a doctor
  • with other acid reducers

Ask a doctor before use if you have
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain 

Stop use and ask a doctor if
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
    • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture

Inactive ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Questions or comments?

call 1-888-287-1915

Tips for Managing Heartburn

 

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking


JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
MADE IN INDIA

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Label)

NDC 49035-505-35
equate TM
Maximum Strength
Famotidine
Tablets USP, 20 mg
ACID REDUCER

• Just one tablet prevents
 and relieves heartburn due
to acid Indigestion

25 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -20 mg (25 Tablets, Container Carton Label)

NDC 49035-505-35

equate TM

Compare  to Maximum Strength
Pepcid® AC Active Ingredient*

Maximum Strength
Famotidine
Tablets USP, 20 mg

Acid Reducer

• Just one
tablet prevents
and relieves
heartburn
due to acid
indigestion

Smaller tablet than the brand
with the same effect 

25 TABLETS



FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-505
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSE 2910 (5 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
FERRIC OXIDE RED 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (Square shaped Biconvex) Size5mm
FlavorImprint CodeCC;59
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-505-351 BOTTLE in 1 CARTON
125 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653104/26/2016
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(49035-505), MANUFACTURE(49035-505)

 
Wal-Mart Stores, Inc.

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Medically reviewed on May 3, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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